A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary Angiography and PTCA in Octogenarians: OCTOPLUS study Y. Louvard, H. Benamer, P. Garot, D. Hildick-Smith, M. Monchi, T. Lefevre, M. Hamon for the OCTOPLUS study group ICPS Massy, CHU “Cote de Nacre” Caen, La Roseraie Aubervilliers, CHU Henri Mondor Creteil, France, Brighton and Sussex UH Brighton, England
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A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary Angiography and PTCA in Octogenarians: OCTOPLUS study Y. Louvard, H. Benamer,
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A Randomized Comparison of Transradial and Transfemoral Approaches for Coronary
Angiography and PTCA in Octogenarians: OCTOPLUS study
Y. Louvard, H. Benamer, P. Garot, D. Hildick-Smith, M. Monchi, T. Lefevre, M. Hamon for the OCTOPLUS study group
ICPS Massy, CHU “Cote de Nacre” Caen, La Roseraie Aubervilliers, CHU Henri Mondor Creteil, France, Brighton and Sussex UH Brighton, England
Aim of the study
This prospective multicentric randomized study was carried out to assess the potential advantages of Transradial (TRA) approach in Octogenarians for diagnostic and intervention procedures
Study Centers
Participating centers: ICPS, Institut hospitalier Jacques Cartier
and Hopital Claude Galien, Massy and Quincy, France (Y. Louvard, C. Loubeyre, P. Garot, T. Lefevre, O. Tavolaro, P. Dumas)
CHU Cote de Nacre, Caen, France (M. Hamon, S. Rigattieri R. Sabatier, G. Grollier)
Hopital Europeen de Paris « La Roseraie », Aubervilliers, France (H. Benamer)
Brighton and Sussex University Hospital, Brighton, UK (D. Hildick-Smith)
Primary Endpoint
Composite approach-related vascular complications leading to a discharge delay:
Vascular surgery, any transfusion, Hb loss > 3g/ 100ml or Ht loss > 10%, acute leg or hand ischemia, false aneurysm, forearm compartment syndrome, other vascular complication leading to discharge delay
Secondary Endpoints
Secondary endpoints:
Previously described approach-related vascular complications plus: hematoma > 3 cms in diameter, cholesterol embolism, TIA or stroke, radial artery occlusion
Coronary angiography and PTCA success rates, complications, procedural and X-Ray exposure times, contrast medium volume
Cost analysis: equipment use for diagnosis and intervention, complication related extra-costs (compression device, hospital stay, biological analysis, echo-doppler, transfusion, surgery…)
Inclusion / Exclusion criteria, Randomization
377 Octogenarian patients randomized, after informed consent, to Radial or Femoral approach using a blinded allocation list for each center
Excepted: - double mammary coronary grafting - known occlusion of 2 femoral or arm arteries - previous approach failure For coronary angiography and/or PCI, whatever the
Independent vascular complication predictive factors by multivariate logistic regression analysis
Population: clinical data (1)
Femoral Radial p value
n= 185 192
Age (y) 83.0+3.1 82.6+2.7 ns
Male (%) 50.8 55.2 ns
Dyslipidemia (%) 43.2 36.5 ns
Hypertension (%) 65.2 57.8 ns
Diabetes (%) 18.4 8.9 0.011
Smoking (%) 5.4 5.2 ns
Weight (%) 68+10 68+12 ns
Height (%) 164+8 164+9 ns
Creatininemia (µmole/L) 114+50 108+40 ns
Femoral Radial p value
n= 185 192
Previous MI (%) 21.6 15.6 Ns
Previous PCI (%) 24.3 14.6 0.024
Previous Bypass surg. (%) 10.8 7.9 Ns
Previous Coro. Angio. (%) 35.7 27.1 Ns
Population: clinical data (2)
39%
11%22%
11%
5%
12%
non ST elevated ACS
ST elevated ACS
Stable angina
Post MI
Valvular surgery
Misc.
35%
10%16%15%
12%12%
Femoral Radial
Population: clinical data (3)
Femoral Radial p value
n= 192 185
Aspirin (%) 78.3 74.0 ns
Vitamin K – (%) 4.9 6.9 ns
LMWH (%) 5.5 8.5 ns
GPIIb/IIIa – (%) 10.3 13.3 ns
Thrombolytics < 24h 2.2 4.3 ns
Population: clinical data (4)
Femoral Radial p value
n= 185 192
Coronary angiography (n / %)
175 / 94.6 180 / 93.7 ns
+ « Ad hoc » PCI (n /%) 87 / 47.0 77 / 40.1 ns
Total PCI (n / %) 97 / 52.4 89 / 46.6 ns
Procedures
Coronary angiography results
Femoral Radial p value
n= 175 180
Normal 14.9 17.2 ns
1 vessel disease 26.5 19.4 ns
2 vessel disease 20.7 25.6 ns
3 vessel disease 38.4 37.8 ns
Prox LAD stenosis 46.7 48.9 ns
Left main stenosis 10.7 16.3 ns
LVEF 58+14 59+13 ns
PCI procedures (1)
Femoral Radial p value
n= 97 89
Dilated lesions (n) 1.5+0.7 1.4+0.8 ns
Dilated vessels (n) 1.2+0.5 1.2+0.4 ns
GPIIb/IIIa per proced. / Total (%) 12.4 10.5 ns
ACT (sec.) 250+62 277+106 ns
Femoral hemostatic devices 51.4 6.7 <0.000
Femoral Radial p value
n= 97 89
Primary success (%) 95.8 96.6 ns
Em. Bypass (%) 3.1 0 ns
Q MI (*Exc. ST+ ACS)(%) 23.7 (0) 21.3 (0) ns
Non Q MI (**Exc. ACS)(%) 16.7 (5.2) 14.6 (1.1) ns
In-hospital Death (%) 3.2 4.3 ns
CK (UI) 401+803 518+869 ns
Excepted in patients presenting with *acute (<24h) or recent ST elevated ACS,Excepted in patients presenting with *acute (<24h) or recent ST elevated ACS,Excepted in patients presenting with **any ACS Excepted in patients presenting with **any ACS
PCI procedures (2)
Femoral Radial P value
Lesions n= 143 128 ns
LAD (%) 42.0 45.3 ns
Circomflex (%) 23.1 16.4 ns
RCA (%) 24.5 31.2 ns
LM (%) 2.8 2.3 ns
PCI procedures (3)
Femoral Radial P value
Lesions n= 143 128 ns
Restenosis (%) 9.9 3.2 0.051
Acute occlusion (%) 13.4 4.2 0.015
CTO (%) 8.8 6.0 ns
Stent (%) 90.9 95.3 ns
Stent number (n) 1.3+0.7 1.2+0.6 ns
Direct stenting (%) 43.9 57.0 0.051
Max. balloon diameter (mm) 3.2+1.5 3.2+0.6 ns
Max. balloon pressure (atm) 14+3 15+3 ns
Angiographic success (%) 97.1 97.6 ns
PCI procedures (4)
Approach changes
RADIAL group: Coronary angiography (n) 18 Right Radial to Femoral (n) 15 Right Radial to Left Radial (n) 2 Left Radial to Right Radial (n) 1 PCI (n) 2 Radial to Femoral (ad hoc)(n) 2 (1)FEMORAL group Coronary angiography (n) 15 Femoral to Radial (n) 13 Right Femoral to Left (n) 2 Femoral to Brachial (n) 1 PCI (n) 2 Femoral to Radial (ad hoc)(n) 2 (0)
Combined end-point of all approach related vascular complications leading to prolonged hospital stay is significantly lower in Octogenarian randomized to Transradial approach for Coronary angiography and/or PCI compared to Transfemoral approach
Approach related vascular complications are more severe in Femoral randomized group and occur mainly in patients actually approached through Femoral artery (cross overs)
Per-protocol analysis shows a higher occurrence rate of the combined end-point and significant blood loss in procedures performed through Femoral artery and a trend for a lower transfusion rate
Conclusion (2)
As in younger patients, for coronary angiography, in intention-to-treat analysis, procedural and X-Ray exposure times are slightly but significantly longer in the Transradial group without differences in contrast medium and equipment use
As in youger patients, for PCI, there is no difference in Procedural and X-Ray exposure times, contrast medium volume and equipment use
Conclusion (3)
Transradial approach is an effective way to reduce the rate of vascular complications related to coronary angiography and PCI in the high risk octogenarian population
Conclusion (4)
Radial vs Femoral coronary angiography: Procedural and X-Ray times
Relative odds with 95% CI for each year compared with 1994. The ORs presented have Relative odds with 95% CI for each year compared with 1994. The ORs presented have been adjusted for the seven variables in the multivariable mortality risk model.been adjusted for the seven variables in the multivariable mortality risk model.
Outcome Trends in the Elderly Undergoing Percutaneous Coronary Interventions: Results in 7,472 Octogenarians
Predicting vascular complications in percutaneous coronary interventions
18,137 PCI pts in northern New England (1997-1999); vascular complication* 2.98%Variables associated with increased risk in the multivariate analysis Age >or=70 OR 2.7 Female sex OR 2.4Body surface area <1.6 m OR 1.9History of congestive heart failure OR 1.4Chronic obstructive pulmonary disease OR 1.5Renal failure OR 1.9Lower extremity vascular disease OR 1.4Bleeding disorder OR 1.68Emergent priority OR 2.3Myocardial infarction OR 1.7Shock OR 1.86>or=1 type B2 lesions OR 1.32 type C lesions OR 1.7 3-vessel PCI OR 1.5Thienopyridines OR 1.4Glycoprotein IIb/IIIa inhibitors OR 1.9
Piper WD Am Heart J. 2003 Jun;145(6):1022-9Piper WD Am Heart J. 2003 Jun;145(6):1022-9
*Vascular complications: access-site injury requiring treatment or bleeding requiring transfusion*Vascular complications: access-site injury requiring treatment or bleeding requiring transfusion
Complications of Cardiac Catheterization in Octogenarians